Mild Depression 2 Week Observational Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
GlaxoSmithKline
Long Island Jewish Medical Center
Rush University Medical Center
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00285831
First received: January 31, 2006
Last updated: October 23, 2008
Last verified: October 2008
  Purpose

The purpose of this study is to assess whether the dysphoric-like depressive characteristics observed in people with epilepsy are unique to this patient population in comparison to three control groups: Mild Depression (enrolled at Stanford University), Migraine Headaches (enrolled at Long Island Jewish Medical Center), and Multiple Sclerosis (enrolled at Rush University Medical Center).


Condition
Depressive Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Dysphoric-Like Disorder of Epilepsy, Is it Unique?

Resource links provided by NLM:


Further study details as provided by Stanford University:

Estimated Enrollment: 120
Study Start Date: December 2005
Detailed Description:

This is a multicenter study consisting of a Screen and Retest phase conducted in two separate days separated by a two-week period. After providing written informed consent and meeting protocol-defined inclusion criteria at Screen, patients will be administered the Wide Range Achievement Test 3 (WRAT3) to ensure adequate word reading ability with which to complete the self-report forms. Patients who achieve a satisfactory score will be interviewed using the Mini International Neuropsychiatric Interview (MINI). Afterwards, each patient will first complete the 46 item Mood and Anxiety Symptom List in Epilepsy (MAS-E) and then five additional questionnaires in random order. Patients will also be given the opportunity to be rated by a proxy (e.g., caregiver, family member, friend) who will also complete the MAS-E.

Patients will return the completed documents to the investigator and be given an additional MAS-E to take home. In the Retest phase, patients will be asked to complete the MAS-E again exactly 14 days from the date of the Screen visit. The proxy will also be given an additional MAS-E and be asked to complete the MAS-E exactly 14 days from completion of the first MAS-E. The documents shall be returned to the clinic via U.S. mail on the same day of completion. It is not necessary to have a proxy to participate in this study.

Total study participation takes 2 weeks and approximately one visit to the clinic for the screening visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria::

" Male or female 18 years of age or older. " Presence of a Depressive disorder that presents as a dysthymic or minor depressive disorder and whose score on the Beck Depression Inventory (BDI) range between 11 and 20. Patients with major depression will be excluded.

" Is currently on stable doses of medications i.e., no change in treatment in the previous 30 days.

" Achieves a satisfactory score on the WRAT3 (standard score is > 69). " Is capable of completing the self-reporting questionnaires. " Is willing and able to provide written informed consent and comply with the study protocol
 Exclusion Criteria:" Presence of a clinically significant comorbidity of an unstable or progressive nature (e.g., psychosis, delirium) that could, in the opinion of the investigator, prevent completion of the questionnaires or warrant immediate medical intervention.

" Participation in an investigational trial within the past 30 days. " Inability to communicate well with site study personnel, e.g. inability to read or understand English, poor mental development or impaired brain function.

" Patients with a clinical picture that meets criterion of major depression.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285831

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
GlaxoSmithKline
Long Island Jewish Medical Center
Rush University Medical Center
Investigators
Principal Investigator: John J Barry Stanford University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00285831     History of Changes
Other Study ID Numbers: 95879
Study First Received: January 31, 2006
Last Updated: October 23, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 01, 2014